The US Food and Drug Administration (USFDA) carried out the inspection at the company's oncology injectable formulation facility at Panelav during the period from 4 October 2022 to 14 October 2022.
Alembic Pharmaceuticals announced that its oncology injectable formulation facility at Panelav received Establishment Inspection Report (EIR) from the US drug regulator. This was pre-approval inspection to cover oncology injectable drug products for which ANDAs were filed with USFDA. The company had also started receiving ANDA approval manufactured at this facility.In a separate announcement today, the drug maker said that it received final approval from USFDA for its ANDA for Desonide cream.
Desonide cream is a low potency corticosteroid indicated for the relief of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
According to IQVIA, Desonide cream has an estimated market size of $12 million for twelve months ended 30 September 2022.
Alembic Pharmaceuticals is a vertically integrated research and development pharmaceutical company. It manufactures and markets generic pharmaceutical products all over the world.
On consolidated basis, the company's net profit declined 18.7% to Rs 133.35 crore despite of 14.1% jump in revenue from operations to Rs 1,475.01 crore in Q2 FY23 over Q2 FY22.
The scrip was down 0.63% at Rs 595.45 on the BSE.
Powered by Capital Market - Live News
Disclaimer: No Business Standard Journalist was involved in creation of this content
